Noninferiority trial supports TAVR option in low-risk patients.

Action Points

Transcatheter aortic valve replacement (TAVR) is as effective and safe as surgical AVR in 2 years of follow-up in patients at low general surgical risk.

Long-term durability of TAVR needs to be determined since TAVR may be used in lower-risk patients with long life expectancy.

Two-year outcomes among lower-risk aortic stenosis patients treated with transcatheter aortic valve replacement (TAVR) were similar to those of surgically-treated patients in the latest analysis of data from the Nordic Aortic Valve Intervention (NOTION) trial.

TAVR (CoreValve, Medtronic) was found to be both safe and effective, with comparable outcomes to surgical aortic valve replacement (SAVR) in patients with a much lower surgical risk than those included in earlier randomized TAVR trials, said NOTION investigator Lars Sondergaard, MD, of Copenhagen University Hospital, Copenhagen, Denmark.

Sondergaard presented the latest findings from the trial on May 19 at EuroPCR 2015, in Paris. One-year follow-up data from NOTION were presented in March at the annual meeting of the American College of Cardiology, held in San Diego, California.

"We can now say that TAVR is as effective and safe as surgical valve replacement in patients with lower surgical risk scores than we have studied so far," Sondergaard told MedPage Today in a telephone interview. "Obviously we still need longer follow-up to answer the durability question."

First Randomized Trial in Lower-Risk Patients

The NOTION study is the first randomized trial to compare transcatheter and surgical bioprosthetic aortic valve outcomes in severe aortic stenosis patients with a low surgical risk.

A total of 139 patients who received the transcatheter aortic valves and 135 patients who had surgical valve replacement completed the trial, and 82% of the patients had a low surgical risk score (STS score of <4%). Patient characteristics, including age, sex, comorbidities, and STS (Society of Thoracic Surgeons) score were similar in the two groups.

The composite rate of death from all causes, stroke, or myocardial infarction was similar in the two groups 1 year after the procedure (TAVR 13.1% versus SAVR 16.3%; P=0.43), and 2 years later (TAVR 15.8% versus SAVR 18.8%; P=0.43).

The death rate at 2 years was 8.0% in the TAVR group and 9.8% in the SAVR patients (P=0.54), and the 2-year cardiovascular death rate was 9.1% in the SAVR patients and 6.5% in the TAVR patients (P=0.40).

Pacemaker implantation was higher in the TAVR group at both 1- and 2-year follow-up, but atrial fibrillation was more common in surgically treated patients. At 2 years, moderate aortic regurgitation was significantly more common in TAVR patients.

Longer Follow-Up Needed to Address Durability

Uncertainty about the durability of transcatheter aortic valve replacement in lower-risk patients with a longer life expectancy remains, but Sondergaard said he does not believe durability will prove to be an issue with the procedure.

"The first NOTION patient is now 5 1/2 years (post procedure), and is doing well," he said.

Thoracic surgeon Michael J. Reardon, MD, of Houston Methodist Debakey Heart and Vascular Center, said 7 or 8 years of follow-up will be needed to establish the durability of TAVR in a younger and healthier population than were recruited for the early, pivotal TAVR trials.

"We can say now that TAVR is noninferior to surgery at 2 years, but that doesn't mean surgery won't turn out to be more durable over the long haul," he said.

Reardon was not involved with the NOTION trial, but he was an investigator for the CoreValve trial, which, along with the pivotal PARTNER trial, established TAVR as a safe and effective alternative to no treatment or surgery in high-surgical risk patients (STS score >10).

"The data are slowly coming in, but it looks like in these lower-risk patients this treatment is going to work," Reardon told MedPage Today.

He said two ongoing randomized clinical trials of intermediate-risk patients -- PARTNER II and SurTAVI -- should provide more definitive data on the use of TAVR in patients who do not have a high surgical risk.

"If TAVR turns out to be noninferior in these trials it would be hard not to recommend this treatment over surgery unless valve durability doesn't hold up," he said.

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